MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE PASSING PIN 13.50 X 2.4MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72201594
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an acl reconstruction procedure, the flexible passing pin broke when over-drilling with clancy flexible drills.It is unknown if all fragments were retrieved from the patient.Although a back-up device was available to complete the procedure, the surgery was delayed for more than 30 min.The patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3,h6: one 72201594 flexible passing pin 13.50 x 2.4mm used in treatment, was not returned for evaluation.Due to unavailability, investigation was limited.The information provided states: ¿during an acl reconstruction procedure, the flexible passing pin broke when over-drilling with clancy flexible drills¿.Per instructions for use: ¿as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in failure.¿ there were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.

• Brand Name: FLEXIBLE PASSING PIN 13.50 X 2.4MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9821718
• Report Number: 1219602-2020-00508
• Device Sequence Number: 11530206
• Product Code: NBH
• UDI-Device Identifier: 03596010601452
• UDI-Public: 03596010601452
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: 72201594
• Device Catalogue Number: 72201594
• Device Lot Number: 2029587
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1